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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05574244
Other study ID # CHUBX 2019/57
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2022
Est. completion date April 15, 2027

Study information

Verified date June 2023
Source University Hospital, Bordeaux
Contact Grégoire ROBERT
Phone 05.57.82.06.87
Email gregoire.robert@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.


Description:

The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment. Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.


Recruitment information / eligibility

Status Recruiting
Enrollment 336
Est. completion date April 15, 2027
Est. primary completion date March 29, 2024
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility Inclusion Criteria: - Man over 40 years old - Indication of surgical management for BPH - Prostate volume =30 cc and =100 cc as evaluated by ultrasonography - IPSS score =12 - Qmax =15 ml/s - Affiliated to French national social security system - wish and be able to comply with planned visits - Able to express his consent - Signed informed consent form Exclusion Criteria: - Unwillingness to accept the treatment - No pre-operative ejaculation or sexuality - Neurological pathology responsible for micturition disorders - History of prostatic surgery - History of prostatic arterial embolisation - Stenosis of the urethra - History of prostate cancer - History of radiotherapy or pelvic surgery - Patient refusing the principle of partial surgery - Life expectancy <3 years - Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. - Participation in another clinical study involving an investigational product within 1 month before study entry.

Study Design


Intervention

Procedure:
Partial surgery preserving the prostatic apex
Partial Endoscopic resection of prostate to conserve apex
Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.

Locations

Country Name City State
France CH Pays d'Aix Aix-en-Provence
France CHU Angers Angers
France Centre Hospitalier Universitaire de Bordeaux Bordeaux
France CHU Mondor Créteil
France Hôpital Claude Huriez Lille
France CHU de Limoges Limoges
France Polyclinique Saint George Nice
France Hôpital cochin Paris
France Hôpital Tenon Paris
France Hôpital Prive Francheville Périgueux
France Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud Pierre-Bénite
France Hôpital Privé des Côtes D'Armor Plérin
France Clinique Pasteur Toulouse
France CHRU Hôpitaux de tours Tours
France Hopital Privé de Versailles, Clinique des Franciscaines Versailles

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points). 6 months after surgery
Secondary Evaluation of ejaculation and global sexual life MSHQ ejd= Male Sexual Health Questionnaire for Ejaculatory Dysfonction Scale score : [1-20] : a higher score mean that the subject have a ejaculatory dysfunction and sexual troubles 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms Urinary Symptom Profile (USP) :
1a+1b+1C [0-9]. A higher score mean that the subject have urinary leakage
2+3+4+4bis+5+6+7 [0-21]. A higher score mean that the subject have voiding urgency
8+9+10 [0-9]. A higher score mean that the subject have voiding problem
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of complication rates Complications based on Clavien Dindo classification 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of ejaculation and global sexual life IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test) 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of ejaculation and global sexual life DAN PPS-SEX= Danish Prostatic Symptom Score -Sexual Questions 1A And B are question about erectyl function Questions 2A, 2B, 3A and 3B are questions about ejaculatory function Questions 4A is a question about global sexual quality of life 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms. 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms Qmax (non-inferiority test) not performed at 1 month 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of complication rates Re-intervention rate 1 month, 3 months, 6 months,12 months, and 36 months after surgery
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